Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD

Ain Shams University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Menorrhagia

Treatments: Drug: Tranexamic Acid; Drug: Diosmin

Study type: Interventional

Funder types: Other

Identifiers

NCT02616731

TXAvsDiosmin-IUDmenorrhagia

Details and patient eligibility

About

To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women complaining from an menorrhagia secondary to a current copper IUD use.
• Age: 20-40years.
• Menorrhagia , will be defined as a PBAC-Score greater than 100.
• No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
• No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
• No drugs decreasing blood coagulation.
• Well fitted IUD not misplaced.

Exclusion criteria

• Age <20y and >40y.
• Irregular menstrual cycle.
• Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
• Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
• Taking drugs decrease blood coagulation.
• Misplaced IUD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tranexamic acid

Active Comparator group

Treatment:

Drug: Tranexamic Acid

Diosmin

Active Comparator group

Treatment:

Drug: Diosmin